“PERA 2025 still says that unmodified human genes as they exist in the human body are not patent eligible, but prior versions of the bill said that isolation of genes was considered a modification.”
Senators Marsha Blackburn (R-TN) and Mazie Hirono (D-HI) today signed onto the Patent Eligibility Restoration Act of 2025 as co-sponsors with Senators Thom Tillis (R-NC) and Chris Coons (D-DE).
PERA 2025 was introduced on May 1 in both the Senate and the House of Representatives by Tillis, Coons and Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA). The bill would essentially eliminate all judicially-created exceptions to U.S. patent eligibility law and has been introduced each year since 2023.
While the 2025 iteration of the bill is largely identical to previous versions introduced in past congressional sessions, PERA 2025 differs in its language relating to human genes. PERA 2025 still says that unmodified human genes as they exist in the human body are not patent eligible, but prior versions of the bill said that isolation of genes was considered a modification. PERA 2025, however, leaves out the world “isolated” and says that “a human gene shall not be considered to be unmodified if that human gene is purified, enriched, or otherwise altered by human activity; or otherwise employed in a useful invention or discovery.”
Last year, during a scheduled markup hearing of PERA, the Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act), and the Inventor Diversity for Economic Advancement (IDEA) Act of 2024, Tillis and Coons announced they would delay moving PERA and PREVAIL forward to the Senate floor. PREVAIL would drastically overhaul Patent Trial and Appeal Board (PTAB) practices.
Commenting on the decision to delay PERA during that hearing, Tillis alluded to forces at work that “may be trying to undermine progress of either PERA or PREVAIL,” and said that despite those efforts, “it’s going to get marked up, so those [trying to thwart the bills] need to get at the table before they get on the table.”
In a Senate IP Subcommittee hearing held in January 2024, one of the eight witnesses testified that “PERA as introduced would stifle innovation and harm patient care in the fields of diagnostic genetic testing and precision medicine.” Richard Blaylock of Pillsbury, Winthrop, Shaw Pittman LLP testified on behalf of Invitae Corporation, a medical genetics company, and said that PERA would “slam the door shut on innovation [in medical diagnostics] and its clinical application in medicine” and that the bill would take us back to the days before the Mayo, Myriad and Alice decisions when clinical testing would require permission from the companies that own the patents.” Former USPTO Director Andrei Iancu, who also testified at that hearing, pushed back strongly on Blaylock’s assertions, but with that issue presumably addressed in the 2025 version of the bill, PERA could see less opposition.
Most, however, agree that it will still be a slow road for any IP bills in the current legislative environment. Senate Director of IP Policy Peter-Anthony Pappas said at IPWatchdog LIVE 2025 in March that it is precisely the non-political nature of IP that tends to send it to the bottom of the pile in the face of other high-profile and highly politically-charged issues. “But that’s exactly why it takes extra work to move the needle,” Pappas said.
Commenting on the bill today in a press release, both Blackburn and Hirono said PERA will help to maintain U.S. leadership in innovation, and Hirono also noted that “[i]mportantly, this legislation only affects patent eligibility, it does nothing to affect the many other requirements for patentability.”
Image Source: Deposit Photos
Author: Konstantinp
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June 24, 2025 05:16 pmMy girls!!!!